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Study Summary
No. 2004-0490:.......Leukemia......Sara Strom......Epidemiology
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Study Summary Title
Study Summary
Number:		2004-0490
Study Title:Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome
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Physician New Patient Referral
Name:Sara StromPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:EpidemiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1631
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:N/AReturn
Visit:		N/A
Treatment
Agents:		NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this research study is to identify biologic and lifestyle factors
that may increase a person's risk of developing acute myeloid leukemia or
myelodysplastic syndrome after treatment for a previous cancer
(treatment-related AML/MDS).
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Study Objectives / Outcomes
Treatment-related Acute Myeloid Leukemia and Myelodysplastic Syndrome (t-AML/MDS) are life-threatening complications of cancer therapy. Among the questions regarding t-AML/MDS development are the roles that genetic susceptibility and epidemiologic factors play. We hypothesize that specific inherited polymorphisms involved in metabolizing chemotherapeutic agents (CYP2E1, CYP3A4, GSTT1, GSTM1, GSTP1, NQO1, MPO, multiple drug resistance), or in DNA repair (XRCC1, XPD, XRCC3), will be associated with the development of t-AML/MDS. Understanding the factors associated with t-AML/MDS development may provide means for primary prevention.

The goal of this project is to identify epidemiologic, clinical, and constitutional markers associated with t-AML/MDS development. We propose to conduct a case-comparison study of t-AML/MDS patients and cancer patients with similar diagnoses and treatment histories as our cases, but have not developed second primary malignancies.

Specific Aims:

1)To identify a well-characterized population of 300 t-AML/MDS patients (cases) among patients enrolled in ongoing AML and MDS studies (Protocols ID00-173 and ID03-0250) by the end of 2007.
    2) To identify and recruit a comparison group consisting of 600 patients treated at MDACC and have not developed second primary malignancies (controls) by the end of 2007. Controls will be matched to cases (2:1) on the cases' first malignancy (site, treatment (chemotherapy and/or radiation therapy), year of diagnosis (+/-3 years)), sex, age (+/- 5 years) and ethnicity.

    3)To evaluate constitutional genetic markers as risk factors for t-AML/MDS development. We propose to evaluate polymorphisms associated with:
      (a)Metabolism of therapeutic agents (CYP2E1, CYP3A4, GSTT1, GSTM1, NQO1, MPO, multiple drug resistance)

      (b)DNA repair (XRCC1, XPD, and XRCC3).

      4)To explore the interplay between clinical, epidemiologic, and molecular factors to determine their significance in predicting risk of t-AML/MDS.
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      Study Status Information
      Study Activation / Registration Date:03/31/2006
      IRB Review and Approval Date:08/04/2004
      Study Type:
      Recruitment Status:Open
      Projected Accrual:600
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      Enrollment Eligibility
      If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
      Inclusion Criteria:1) Age 18 years or older

      2) Willing and able to provide written informed consent and authorization

      3) Willing to donate a saliva sample or 10 ml of blood and to complete a self-administered or personal interview

      4) A histologically confirmed diagnosis of AML or MDS (cases only)

      5) A history of a previous primary malignancy that was treated with chemotherapy and/or radiation therapy (cases only)

      6) Enrolled in leukemia/MDS studies under protocol ID00-173 or ID03-0250 (cases only)

      7) Treated for a primary malignancy at MDACC (controls only)

      8) Matched to cases (2:1) by cases' prior malignancy(site, treatment (chemo and/or radiation), year of diagnosis (+/- 3 years)), age (+/- 5 years), sex, and ethnicity. (controls only)
      Exclusion Criteria:1) Under 18 years of age

      2) History of second primary malignancy (controls only)
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      Links
      Registration Number: NCT00525746
      Study Information on Clinical Trials Registry (clinicaltrials.gov)
      Other Links:
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      Results

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